Nancy Dreyer served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences Inc and Quintiles, and CEO of Epidemiology Resources Inc. prior to switching to consultancy. She maintains active practice in the biopharmaceutical industry. Her primary research interest is to advance use of RWE including patient-generated health data, electronic medical records, medical and pharmacy claims, data linkage and data integration for studies of safety, effectiveness and natural history. She is a Fellow of ISPE, a Science and Policy Advisor and Fellow of DIA, Adjunct Professor of Epidemiology at the Univ of North Carolina at Chapel Hill and serves on ISPOR's RWE Leadership Team.

Dr. Iyasu is a former head of Epidemiology of Merck & Co (2015-2022) and former head of the Office of Pharmacovigilance and Epidemiology at the Center for Drug Evaluation and Research, Food and Drug Administration (2008-2015). He is currently an independent consultant to life science companies on drug safety epidemiology, real-world data (RWD) and real-world evidence (RWE) to support clinical development, regulatory and reimbursement strategies and life cycle management.

Peter Stein, MD, is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. A nationally-recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late stage development, diabetes, and endocrinology at Merck Research Laboratories.

Tony is the Head of the Regulatory Science and Innovation Task Force (TRS) responsible for providing leadership in the Task Force and the Agency to enable its continuous future proofing through operation of a regulatory science observatory, addressing key scientific and technological trends and their translation through the development of regulatory science strategy, planning and governance. He also provides leadership for supply and availability of medicines under the extended mandate of the Agency.